NCT00888745已完成1 期
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Safety and tolerability of PRO283698 assessed through the incidence of adverse events
研究概览
简要总结
This is a Phase I multicenter study that will be conducted in the United States and Europe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA diagnosed according to the American College of Rheumatology (ACR)
排除标准
- •Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
- •Clinically significant abnormal ECG
- •History of anaphylactic reactions
- •Positive hepatitis C antibody or hepatitis B surface antigen
- •Positive serology for human immunodeficiency virus (HIV) by quantitative polymerase chain reaction
- •A history of an autoimmune disease other than RA (other than secondary Sjogren syndrome)
- •Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty syndrome
- •Malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
- •Recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
- •Concomitant therapy with a biologic agent
- •Recent exposure to any investigational agent
- •Any current or recent signs or symptoms of infection requiring parenteral antibiotic administration
- •Hospitalization for a clinically relevant event within the 4 weeks prior to screening
研究组 & 干预措施
1
Experimental
干预措施: PRO283698 (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability of PRO283698 assessed through the incidence of adverse events
时间窗: Through study completion or early study discontinuation
次要结局
- Pharmacokinetic parameters(Following study drug administration)
研究者
研究点 (1)
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